COVID-19 Vaccine Explainer

11 JUNE 20211

COVID-19 Vaccine (Vero Cell),

Inactivated, CoronaVac®
Manufacturer: Sinovac Life Sciences Co., Ltd

The COVID-19 Vaccine (Vero Cell) Inactivated, CoronaVac® is an inactivated vaccine

against coronavirus disease 2019 (COVID-19) which stimulates the body’s immune
system without risk of causing a disease. Once the inactivated vaccine gets presented
to the body’s immune system, the production of antibodies is stimulated which
makes the body ready to respond to an infection with live SARS-CoV-2. This vaccine is
adjuvanted (with aluminum hydroxide), to boost the response of the immune system.

Efficacy shown in phase 3 trial in Brazil in participants who received 2 doses of

vaccine at an interval of 14 days had the efficacy of 51% against symptomatic SARS-
CoV-2 infection, 100% against severe COVID-19 and 100% against hospitalization
starting 14 days after receiving the second dose. Vaccine efficacy was maintained
in groups with and without comorbidities and irrespective of previous SARS-CoV-2 infection for the median
follow-up duration of 73 days.

Preliminary findings from a post-introduction cohort study in Chile that involved about 2.5 million individuals
that had received two doses and 2.1 million individuals that received one dose (≥16 years), suggest vaccine
effectiveness starting 14 days after the second dose to be 67% against symptomatic SARS-CoV-2 infections,
85% against hospitalization, and 80% against death. Protection 14 days after the first dose was limited, up to
administration of the second dose.

The data reviewed at this time support the conclusion that the known and potential benefits of CoronaVac®
vaccine outweigh the risks that are known or considered possible.

Date of WHO Emergency Use Listing (EUL) recommendation: 1 June 2021

Date of prequalification (PQ): not yet prequalified
National regulatory authorities (NRAs) can use reliance approaches for in-country authorization of vaccines
based on WHO PQ/EUL or emergency use authorizations by stringent regulatory authorities (SRAs).

Product characteristics
Presentation Fully liquid, inactivated, adjuvanted, preservative-free suspension for injection in
vials and non-AD pre-filled syringes
Number of doses Single-dose (one dose 0.5 mL)
Vaccine syringe type Two available presentations:
and needle size 1. Non-auto-disable (non-AD) syringe: 0.5 mL
2. Vials, for which the following is needed:
• Auto-disable (AD) syringes: 0.5 mL
• Needles for intramuscular injection 23G × 1” (0.60 × 25 mm)

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Contents will be updated as new information becomes available.

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COVID-19 Vaccine (Vero Cell), Inactivated, CoronaVac®

Schedule and administration

Recommended for 18 to 59 years of age (as per WHO EUL)
age Based on the data reviewed, WHO SAGE recommends use in persons aged 18 years
and above.
Recommended 2 doses (0.5 mL each) at a recommended interval of 2 to 4 weeks:
schedule Dose 1: at the start date
Dose 2: 14 to 28 days after first dose.

If the second dose is inadvertently administered earlier than 2 weeks after the first,
the dose does not need to be repeated.
If the second dose is inadvertently delayed beyond 4 weeks, it should be given at
the earliest possible opportunity.

It is recommended that all vaccinated individuals receive two doses. According to

current recommendation, the same product should be used for both doses.
Route and site of Intramuscular (i.m.) administration
administration The preferred site is deltoid muscle.
Dosage 0.5 mL (single dose)
Diluent None needed
Mixing syringe None needed
Preparation/ No dilution is required.
reconstitution/
dilution Vaccine administration:
requirement 1. Vaccine is ready to use, do not dilute.
2. Inspect the vial/monodose syringe to make sure that the liquid is opalescent
suspension, milky-white in colour.
3. If the stratified precipitate is formed, disperse it by shaking the vial/monodose
syringe.
4. Monodose syringes are ready to use. When using vaccine vials, draw up the
vaccine from the vial at the time of administration, pre-loading of syringes is not
recommended.
5. Use the vaccine from the vial immediately after loading the syringe as
CoronaVac® contains no preservative.

During vaccination session, vials should be kept between +2 and +8 °C and

protected from light.
Multi-dose vial Not applicable
policy
Contraindications • Known history of anaphylaxis to any component of the vaccine.
• Persons who developed anaphylaxis after the first dose should not receive a
second dose of the CoronaVac® vaccine.
Precautions • All persons should be vaccinated in health-care settings where appropriate
medical treatment is available in case of allergic reactions. An observation
period of 15 minutes after vaccination should be ensured.
• Vaccination of people suffering from acute severe febrile illness (body
temperature over 38.5 °C) should be postponed until they are afebrile.
• Vaccination of persons with acute COVID-19 should be postponed until they
have recovered from acute illness and criteria for discontinuation of isolation
have been met.

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COVID-19 Vaccine (Vero Cell), Inactivated, CoronaVac®
Schedule and administration contd.
Special population
groups (based on
available data as of
30 April 2021)
• For persons with comorbidities, vaccine efficacy was demonstrated in clinical
trials among individuals with obesity and hypertension, though the numbers
were too small to allow firm conclusions across other comorbidities. However,
vaccination is recommended for persons with comorbidities that have been
identified as increasing the risk of severe COVID-19.
• The vaccine efficacy in persons aged ≥60 years could not be determined as the
representation of participants above 60 years of age in the clinical trials was
insufficient. However, recent preliminary post-introduction data from Chile
suggested consistent vaccine effectiveness across all age groups. In adults aged
60 years and above, vaccine effectiveness starting 14 days after dose 2 was
67.4% against symptomatic SARS-CoV-2 infection, 83.3% against hospitalization,
and 83% against death.
• Available data on administration in pregnant women are insufficient to assess
vaccine efficacy or vaccine-associated risks in pregnancy. However, this is
an inactivated vaccine with an adjuvant that is routinely used in many other
vaccines with a documented good safety profile, including in pregnant women.
Until data to evaluate safety and immunogenicity in pregnant women are
available, WHO recommends the use of CoronaVac in pregnant women when
the benefits of vaccination outweigh the potential risks. To help pregnant
women make this assessment, they should be provided with information
about the risks of COVID-19 in pregnancy (including, for example, that some
pregnant women are at increased risk of infection, or have comorbidities that
add to their risk of severe disease), the likely benefits of vaccination in the
current epidemiological context, and the current limitations of the safety data
in pregnant women. WHO does not recommend pregnancy testing prior to
vaccination. WHO does not recommend delaying pregnancy or terminating
pregnancy because of vaccination.
• There are no data on potential benefits or risks of the vaccine to breastfed
children. As this is not a live virus vaccine, it is unlikely to pose a risk to
the breastfeeding child. Vaccine effectiveness is expected to be similar in
lactating women as in other adults. WHO does not recommend discontinuing
breastfeeding after vaccination.
• Studies in persons living with HIV (PLWH) are underway; data on administration
of the vaccine are currently insufficient to allow assessment of vaccine efficacy
for PLWH. It is possible that their immune response to the vaccine may be
reduced. PLWH who are a part of a group recommended for vaccination may
be vaccinated, given that the vaccine is non-replicating. Where possible,
information and counselling should be provided to inform individual benefit-
risk assessment. Testing for HIV infection prior to vaccine administration is not
necessary.
• Available data are currently insufficient to access vaccine efficacy or vaccine-
associated risks in severely immunocompromised persons, who may
have diminished immune response to vaccine. Nevertheless, if part of a
recommended group for vaccination, they may be vaccinated, given that the
vaccine is non-replicating. Information and, where possible, counselling about
vaccine safety and efficacy profiles in immunocompromised persons should be
provided to inform individual benefit–risk assessment.
• For persons who have received monoclonal antibodies or convalescent plasma
as part of COVID-19 treatment, vaccination should be deferred for at least 90
days to avoid interference of treatment with vaccine-induced immune response
as a precautionary measure.
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COVID-19 Vaccine (Vero Cell), Inactivated, CoronaVac®
Stability and storage
Vaccine storage tem-
perature
Shelf life at different
temperatures
Freeze sensitivity
Light sensitivity
Conditions before use
Wastage rates
Buffer stock needed
Labelling and packaging
Vaccine Vial Monitor
(VVM)
Information on vial
label (for vials and
pre-filled syringes)
Information on
secondary packaging
(for vials and pre-
filled syringes)
Information on
tertiary packaging
(for vials and pre-
filled sy-ringes)
Secondary packaging
dimension and
volume (for vials and
pre-filled syringes)
Tertiary packaging
dimension and
volume (for vials and
pre-filled syringes)
Store in the original carton in a refrigerator at +2 to +8 °C.
Do not store in a freezer.
Unopened vials in a refrigerator between +2 and +8 °C: 12 months or until
expiry date as stated on the label.
Do not freeze.
Store in the original carton to protect from light.
Avoid exposure to direct sunlight and ultraviolet light.
Vaccine is ready to use; it should be kept cooled at +2 °C to +8 °C.
Will be dependent on country context.
Will be dependent on country context.
Initial pandemic supply will not include a VVM.
Name and type of vaccine, method of administration, dosage, storage
temperature, manufacturing and expiry date, batch number
Name of vaccine, pharmaceutical form, method of administration, dosage,
composition (active substance and excipients), manufacturing date, batch
number, authorisation number, name and address of manufacturer
Type of vaccine, name of manufacturer, presentation, batch
number, date of expiry, quantity and storage conditions
Single-dose vials:
Carton holding 40 vials/1 dose: 15.6 cm × 9.5 cm × 4.4 cm
Volume per dose: 16.30 cm³
Monodose pre-filled syringes:
Carton holding 10 monodose pre-filled syringes: 19.4 cm × 11.3 cm × 1.9 cm
Volume per dose: 41.65 cm³
Single-dose vials:
Outer box containing 30 cartons with a total of 1200 vials (1200 doses)
External dimensions: 32.7 cm × 30.2 cm × 24.6cm
Gross weight: ≤ 50 kg
Monodose pre-filled syringes:
Outer box containing 60 cartons with a total of 600 pre-filled syringes (600 doses)
External dimensions: 40.2 cm × 30.6 cm × 24.3 cm
Gross weight: ≤ 50 kg
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COVID-19 Vaccine (Vero Cell), Inactivated, CoronaVac®

Safety information*
Possible events Observed events frequent, mostly mild to moderate and short lived
(by frequency)
Very common (≥1/10):
Headache, pain at the injection site, fatigue
Common (≥1/100 to ˂1/10):
Injection site: swelling, itching, redness, induration; chills, myalgia, arthralgia,
nasal congestion, cough, runny nose, sore throat, pruritus, loss of appetite,
nausea, diarrhoea, abdominal pain
Uncommon (≥1/1 000 to ˂1/100):
Injection site: warmth, swelling; fever ≥37.3 °C, tremor, dizziness, drowsiness,
flushing, vomiting, mucocutaneous rash, hypersensitivity
Rare (≥1/10 000 to ˂ 1/1 000):
Ocular congestion, eyelid swelling, hot flashes, nose bleeds, diminished sense of
smell, abdominal distension, constipation, muscle spasms
Not known (cannot be estimated from available data):
Anaphylaxis

Post-marketing passive surveillance, limited to China, Indonesia, Brazil and Chile,

Co-administration of
vaccines/medicines
*From clinical studies.
did not identify any unexpected signals to date.
There should be a minimum interval of 14 days between administration of this
and any other vaccine against other diseases, until data on co-administration
become available.

Important reminders
Vaccination session and vaccine administration:
Before, during, and after vaccination, all people should continue to follow current guidance for protection
from COVID-19 in their area (e.g. wearing a mask, keeping physical distance, hand hygiene).
Vaccination should be offered regardless of a person’s history of symptomatic or asymptomatic SARS-
CoV-2 infection. Viral or serological testing is not recommended for the purpose of decision-making about
vaccination. Based on available data, symptomatic reinfection in uncommon within 6 months after an initial
natural infection, and in the context of limited vaccine supply, persons with PCR-confirmed SARS-CoV-2
infection in the preceding 6 months may choose to delay vaccination until near the end of this period.
However, emerging data indicate that symptomatic reinfection may occur in settings where variants with
evidence of immune escape are circulating, and in these settings, earlier vaccination after infection may
be advisable. The length of this time period may be revised when more data on duration of immunity after
natural infection become available.
The presence of a minor infection such as a cold or low-grade fever should not delay vaccination.
A person with acute PCR-confirmed COVID-19 should not be vaccinated until after they have recovered from
acute illness and the criteria for discontinuation of isolation have been met. The optimal minimum interval
between a natural infection and vaccination is not yet known.
Before vaccination, advise vaccine recipient about possible post-vaccination symptoms and observe post-
vaccination for at least 15 minutes.

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To alleviate post-vaccination symptoms, antipyretic or analgesics may be taken (routine prophylaxis to

prevent the symptoms is not recommended due to lack of information on impact on immune response).
Encourage a vaccine recipient to complete the vaccination series to optimize protection and schedule
the time for the second dose. The same vaccine product should be used for both doses. When
scheduling vaccination for occupational groups (e.g. health workers) consideration should be given to the
reactogenicity profile observed in clinical trials, occasionally leading to time off work in the 24–48 hours
following vaccination.

SARS-CoV-2 variants
As SARS-CoV-2 viruses undergo evolution, new variants may be associated with higher transmissibility,
disease severity, risk of reinfection, or a change in antigenic composition. At the time of the clinical trial in
Brazil, the variant of concern P.1 was just starting to emerge and other variants of concern (e.g. B.1.1.7 and
B1.351) were not circulating.
Preliminary findings from vaccine effectiveness study in Manaus, Brazil estimated effectiveness of
CoronaVac® to be 49.6% against symptomatic infection following at least one dose and in the context of
broad circulation of the P.1 variant (P.1 accounted for 75% of genotyped SARS-CoV-2 samples at the peak
of its epidemic in January 2021). Vaccine effectiveness assessed in a cohort of health workers in Sao Paulo,
Brazil was 50.7% two weeks after the second dose, also in the context of circulating variants of concern,
mainly P.1. High vaccine effectiveness against hospitalizations and deaths demonstrated in post-introduction
study in Chile was in the context of circulating B.1.1.7 and P.1.
WHO currently recommends the use of CoronaVac® even if the variants are present in the country.
Countries should conduct a benefit-risk assessment according to the local epidemiological situation
including the extent of circulating virus variants. Countries using the vaccine in the presence of variants are
encouraged to monitor vaccine effectiveness and study eventual breakthrough infections due to variants.

SARS-CoV-2 tests
CoronaVac® contains inactivated SARS-CoV-2 virus which elicits immunological response to the spike and
nucleocapsid protein. As currently available antibody tests for SARS-CoV-2 assess levels of IgM and/or
IgG to the spike or the nucleocapsid protein, a positive test could indicate either prior infection or prior
vaccination. Antibody testing is not currently recommended to assess immunity to COVID-19 following
CoronaVac® vaccination.

Resources and more information at:

https://apps.who.int/iris/bitstream/handle/10665/341454/WHO-2019-nCoV-vaccines-SAGE-
recommendation-Sinovac-CoronaVac-2021.1-eng.pdf
https://extranet.who.int/pqweb/vaccines/who-recommendation-sinovac-covid-19-vaccine-vero-cell-
inactivated-coronavac

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